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NCT00098774 · FLOW

Participant flow

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma · Source last updated 2016-07-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
    id
    FG000
    title
    Intensive Combination Chemo & Immunotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Failed (to respond) during induction
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
recruitment Details
Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.
Complete source fields
groups
  1. description
    Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
    id
    FG000
    title
    Intensive Combination Chemo & Immunotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Failed (to respond) during induction
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
recruitment Details
Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.

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Preserved source evidence · Not medical advice